ID

37427

Description

Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH); ODM derived from: https://clinicaltrials.gov/show/NCT02290613

Link

https://clinicaltrials.gov/show/NCT02290613

Keywords

Versions (1)
  1. 7/25/19 7/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Systemic Sclerosis NCT02290613

English

Eligibility Systemic Sclerosis NCT02290613

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. mpap 21-24 mmhg, tpg > 11mmhg, pawp <15 mmhg and/or
Description

Mean pulmonary arterial pressure | Pulmonary artery pressure Gradient | Pulmonary Wedge Pressure

Data type

boolean

Alias
UMLS CUI [1]
C3854605
UMLS CUI [2,1]
C0428642
UMLS CUI [2,2]
C0812409
UMLS CUI [3]
C0034094
2. exercise induced elevated mpap-values >30 mmhg, pawp <18 mmhg; tpg >15 mmhg, as defined in saggar et al. (2012) without left heart or severe lung disease or systemic arterial hypertension
Description

Mean pulmonary arterial pressure increased Exercise induced | Pulmonary Wedge Pressure Exercise induced | Pulmonary artery pressure Gradient Exercise induced | Heart Disease Left sided Absent | Lung disease Severe Absent | Hypertensive disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4087413
UMLS CUI [1,2]
C0239313
UMLS CUI [2,1]
C0034094
UMLS CUI [2,2]
C0239313
UMLS CUI [3,1]
C0428642
UMLS CUI [3,2]
C0812409
UMLS CUI [3,3]
C0239313
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0443246
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0024115
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0020538
UMLS CUI [6,2]
C0332197
3. adult patients having completed his/her 18th birthday
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
4. patients with definite diagnosis of systemic sclerosis using the scleroderma criteria of the american rheumatism association
Description

Systemic Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0036421
5. ssc-disease duration >3 years
Description

Systemic Sclerosis Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0036421
UMLS CUI [1,2]
C0872146
6. able to understand and willing to sign the informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
7. negative pregnancy test at the start of the trial and appropriate contraception throughout the study for women with child-bearing potential.
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any connective tissue diseases (ctd) other than ssc
Description

Connective Tissue Diseases | Exception Systemic Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0009782
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036421
2. pulmonary hypertension (ph) confirmed by right heart catheter (rhc) before enrolment, i.e. mpap ≥25 mmhg at rest
Description

Pulmonary Hypertension Catheterization of right heart | Mean pulmonary arterial pressure At rest

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0189896
UMLS CUI [2,1]
C3854605
UMLS CUI [2,2]
C0443144
3. patients presenting normal mpap values, i.e. mpap<21 mmhg at rest, ≤30 mmhg during exercise, pawp >=15 mmhg at rest or <=18 mmhg during exercise
Description

Mean pulmonary arterial pressure Normal | Mean pulmonary arterial pressure At rest | Mean pulmonary arterial pressure Exercise induced | Pulmonary Wedge Pressure At rest | Pulmonary Wedge Pressure Exercise induced

Data type

boolean

Alias
UMLS CUI [1,1]
C3854605
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C3854605
UMLS CUI [2,2]
C0443144
UMLS CUI [3,1]
C3854605
UMLS CUI [3,2]
C0239313
UMLS CUI [4,1]
C0034094
UMLS CUI [4,2]
C0443144
UMLS CUI [5,1]
C0034094
UMLS CUI [5,2]
C0239313
4. ongoing or a history of >2 weeks of continued use of therapies that are considered definitive ph treatment: endothelin receptor antagonists (era; e.g. bosentan, ambrisentan), phosphodiesterase type 5 inhibitors (pde5; e.g. sildenafil, tadalafil, vardenafil), prostanoids (e.g. epoprostenol, treprostinil, iloprost, beraprost) and soluble guanylate cyclase stimulator (e.g. riociguat). intermittent use of pde5 inhibitors for male erectile dysfunction is permitted.
Description

Therapy Pulmonary Hypertension | Endothelin receptor antagonist | bosentan | ambrisentan | Phosphodiesterase 5 inhibitor | sildenafil | tadalafil | vardenafil | Prostaglandins | Epoprostenol | Treprostinil | Iloprost | beraprost | Soluble Guanylate Cyclase Stimulator | riociguat

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0020542
UMLS CUI [2]
C1134681
UMLS CUI [3]
C0252643
UMLS CUI [4]
C1176329
UMLS CUI [5]
C1318700
UMLS CUI [6]
C0529793
UMLS CUI [7]
C1176316
UMLS CUI [8]
C0971579
UMLS CUI [9]
C0033554
UMLS CUI [10]
C0033567
UMLS CUI [11]
C1145760
UMLS CUI [12]
C0079594
UMLS CUI [13]
C0053336
UMLS CUI [14]
C3819023
UMLS CUI [15]
C2717561
5. except for diuretics and corticosteroids medical treatment should not be expected to change 4 weeks prior inclusion into the study and during the entire 12-week study period.
Description

Exception Diuretics | Exception Adrenal Cortex Hormones | Therapeutic procedure unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0012798
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001617
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0442739
6. known intolerance to ambrisentan or one of its excipients
Description

Intolerance to Ambrisentan | Intolerance to Ambrisentan Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1176329
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1176329
UMLS CUI [2,3]
C0015237
7. clinically significant anemia (hemoglobin concentration of less than 75% of the lower limit of normal, lln)
Description

Anemia | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
8. forced vital capacity (fvc) <60%, forced expiratory volume in first second (fev1) <65%
Description

FVC | FEV1

Data type

boolean

Alias
UMLS CUI [1]
C3714541
UMLS CUI [2]
C0849974
9. severe interstitial lung disease, idiopathic pulmonary fibrosis
Description

Interstitial Lung Disease Severe | Idiopathic Pulmonary Fibrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1800706
10. renal insufficiency (glomerular filtration rate [gfr] <60 ml/min/1.73m2 for at least 3 months)
Description

Renal Insufficiency | Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0017654
11. baseline values of hepatic aminotransferases (alt and/or ast) >3 x upper limit of normal (uln)
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
12. systolic blood pressure <85 mmhg;
Description

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
13. evidence of inadequately treated blood pressure >160/90 mmhg and/or blood pressure during exercise >220/120 mmhg
Description

Blood pressure determination | Therapy Inadequate | Blood pressure determination During Exercise

Data type

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0005824
UMLS CUI [3,2]
C0347984
UMLS CUI [3,3]
C0015259
14. patients referred with clinically significant overt heart failure
Description

Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
15. clinically significant fluid retention
Description

Body fluid retention

Data type

boolean

Alias
UMLS CUI [1]
C0268000
16. previous evidence or diagnosis of clinically relevant left heart disease, i.e. at least one of the following: previous echocardiography with estimated left ventricular (lv) ejection fraction <50%, previous history of cardiogenic pulmonary edema, increased size of left atrium (>50 mm)
Description

Heart Disease Left sided | Estimated Left Ventricular Ejection Fraction Echocardiography | Cardiogenic pulmonary edema | Left atrium Size Increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443246
UMLS CUI [2,1]
C4525751
UMLS CUI [2,2]
C0013516
UMLS CUI [3]
C0398350
UMLS CUI [4,1]
C0225860
UMLS CUI [4,2]
C0456389
UMLS CUI [4,3]
C0205217
17. known significant diastolic dysfunction associated with clinical heart failure
Description

Diastolic dysfunction Associated with Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0520863
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0018801
18. known coronary disease or significant valvular heart disease
Description

Coronary Artery Disease | Heart valve disease

Data type

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0018824
19. known congenital heart defects such as single ventricle, transposition, eisenmenger
Description

Congenital Heart Defects | Single Ventricle | Transposition | Eisenmenger Complex

Data type

boolean

Alias
UMLS CUI [1]
C0018798
UMLS CUI [2]
C3274516
UMLS CUI [3]
C0040759
UMLS CUI [4]
C0013743
20. known hypertrophic cardiomyopathy or left ventricular hypertrophy (interventricular septum thickness (ivs) or posterior wall thickness (pwd) >1.2 cm)
Description

Hypertrophic Cardiomyopathy | Left Ventricular Hypertrophy | Interventricular septum thickness increased | Posterior wall thickness increased

Data type

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0149721
UMLS CUI [3]
C3553443
UMLS CUI [4]
C3553444
21. participation in any clinical drug trial within 4 weeks prior to screening of this study and/or who is scheduled to receive another investigational medicinal product (imp) during the course of this study
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
22. pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Systemic Sclerosis NCT02290613

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Mean pulmonary arterial pressure | Pulmonary artery pressure Gradient | Pulmonary Wedge Pressure
Item
1. mpap 21-24 mmhg, tpg > 11mmhg, pawp <15 mmhg and/or
boolean
C3854605 (UMLS CUI [1])
C0428642 (UMLS CUI [2,1])
C0812409 (UMLS CUI [2,2])
C0034094 (UMLS CUI [3])
Mean pulmonary arterial pressure increased Exercise induced | Pulmonary Wedge Pressure Exercise induced | Pulmonary artery pressure Gradient Exercise induced | Heart Disease Left sided Absent | Lung disease Severe Absent | Hypertensive disease Absent
Item
2. exercise induced elevated mpap-values >30 mmhg, pawp <18 mmhg; tpg >15 mmhg, as defined in saggar et al. (2012) without left heart or severe lung disease or systemic arterial hypertension
boolean
C4087413 (UMLS CUI [1,1])
C0239313 (UMLS CUI [1,2])
C0034094 (UMLS CUI [2,1])
C0239313 (UMLS CUI [2,2])
C0428642 (UMLS CUI [3,1])
C0812409 (UMLS CUI [3,2])
C0239313 (UMLS CUI [3,3])
C0018799 (UMLS CUI [4,1])
C0443246 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0024115 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0020538 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Adult | Age
Item
3. adult patients having completed his/her 18th birthday
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Systemic Sclerosis
Item
4. patients with definite diagnosis of systemic sclerosis using the scleroderma criteria of the american rheumatism association
boolean
C0036421 (UMLS CUI [1])
Systemic Sclerosis Disease length
Item
5. ssc-disease duration >3 years
boolean
C0036421 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Informed Consent
Item
6. able to understand and willing to sign the informed consent form
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
7. negative pregnancy test at the start of the trial and appropriate contraception throughout the study for women with child-bearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Connective Tissue Diseases | Exception Systemic Sclerosis
Item
1. any connective tissue diseases (ctd) other than ssc
boolean
C0009782 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036421 (UMLS CUI [2,2])
Pulmonary Hypertension Catheterization of right heart | Mean pulmonary arterial pressure At rest
Item
2. pulmonary hypertension (ph) confirmed by right heart catheter (rhc) before enrolment, i.e. mpap ≥25 mmhg at rest
boolean
C0020542 (UMLS CUI [1,1])
C0189896 (UMLS CUI [1,2])
C3854605 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
Mean pulmonary arterial pressure Normal | Mean pulmonary arterial pressure At rest | Mean pulmonary arterial pressure Exercise induced | Pulmonary Wedge Pressure At rest | Pulmonary Wedge Pressure Exercise induced
Item
3. patients presenting normal mpap values, i.e. mpap<21 mmhg at rest, ≤30 mmhg during exercise, pawp >=15 mmhg at rest or <=18 mmhg during exercise
boolean
C3854605 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C3854605 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C3854605 (UMLS CUI [3,1])
C0239313 (UMLS CUI [3,2])
C0034094 (UMLS CUI [4,1])
C0443144 (UMLS CUI [4,2])
C0034094 (UMLS CUI [5,1])
C0239313 (UMLS CUI [5,2])
Therapy Pulmonary Hypertension | Endothelin receptor antagonist | bosentan | ambrisentan | Phosphodiesterase 5 inhibitor | sildenafil | tadalafil | vardenafil | Prostaglandins | Epoprostenol | Treprostinil | Iloprost | beraprost | Soluble Guanylate Cyclase Stimulator | riociguat
Item
4. ongoing or a history of >2 weeks of continued use of therapies that are considered definitive ph treatment: endothelin receptor antagonists (era; e.g. bosentan, ambrisentan), phosphodiesterase type 5 inhibitors (pde5; e.g. sildenafil, tadalafil, vardenafil), prostanoids (e.g. epoprostenol, treprostinil, iloprost, beraprost) and soluble guanylate cyclase stimulator (e.g. riociguat). intermittent use of pde5 inhibitors for male erectile dysfunction is permitted.
boolean
C0087111 (UMLS CUI [1,1])
C0020542 (UMLS CUI [1,2])
C1134681 (UMLS CUI [2])
C0252643 (UMLS CUI [3])
C1176329 (UMLS CUI [4])
C1318700 (UMLS CUI [5])
C0529793 (UMLS CUI [6])
C1176316 (UMLS CUI [7])
C0971579 (UMLS CUI [8])
C0033554 (UMLS CUI [9])
C0033567 (UMLS CUI [10])
C1145760 (UMLS CUI [11])
C0079594 (UMLS CUI [12])
C0053336 (UMLS CUI [13])
C3819023 (UMLS CUI [14])
C2717561 (UMLS CUI [15])
Exception Diuretics | Exception Adrenal Cortex Hormones | Therapeutic procedure unchanged
Item
5. except for diuretics and corticosteroids medical treatment should not be expected to change 4 weeks prior inclusion into the study and during the entire 12-week study period.
boolean
C1705847 (UMLS CUI [1,1])
C0012798 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0442739 (UMLS CUI [3,2])
Intolerance to Ambrisentan | Intolerance to Ambrisentan Excipient
Item
6. known intolerance to ambrisentan or one of its excipients
boolean
C1744706 (UMLS CUI [1,1])
C1176329 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1176329 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Anemia | Hemoglobin measurement
Item
7. clinically significant anemia (hemoglobin concentration of less than 75% of the lower limit of normal, lln)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
FVC | FEV1
Item
8. forced vital capacity (fvc) <60%, forced expiratory volume in first second (fev1) <65%
boolean
C3714541 (UMLS CUI [1])
C0849974 (UMLS CUI [2])
Interstitial Lung Disease Severe | Idiopathic Pulmonary Fibrosis
Item
9. severe interstitial lung disease, idiopathic pulmonary fibrosis
boolean
C0206062 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1800706 (UMLS CUI [2])
Renal Insufficiency | Glomerular Filtration Rate
Item
10. renal insufficiency (glomerular filtration rate [gfr] <60 ml/min/1.73m2 for at least 3 months)
boolean
C1565489 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
11. baseline values of hepatic aminotransferases (alt and/or ast) >3 x upper limit of normal (uln)
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Systolic Pressure
Item
12. systolic blood pressure <85 mmhg;
boolean
C0871470 (UMLS CUI [1])
Blood pressure determination | Therapy Inadequate | Blood pressure determination During Exercise
Item
13. evidence of inadequately treated blood pressure >160/90 mmhg and/or blood pressure during exercise >220/120 mmhg
boolean
C0005824 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0005824 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
C0015259 (UMLS CUI [3,3])
Heart failure
Item
14. patients referred with clinically significant overt heart failure
boolean
C0018801 (UMLS CUI [1])
Body fluid retention
Item
15. clinically significant fluid retention
boolean
C0268000 (UMLS CUI [1])
Heart Disease Left sided | Estimated Left Ventricular Ejection Fraction Echocardiography | Cardiogenic pulmonary edema | Left atrium Size Increased
Item
16. previous evidence or diagnosis of clinically relevant left heart disease, i.e. at least one of the following: previous echocardiography with estimated left ventricular (lv) ejection fraction <50%, previous history of cardiogenic pulmonary edema, increased size of left atrium (>50 mm)
boolean
C0018799 (UMLS CUI [1,1])
C0443246 (UMLS CUI [1,2])
C4525751 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0398350 (UMLS CUI [3])
C0225860 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0205217 (UMLS CUI [4,3])
Diastolic dysfunction Associated with Heart failure
Item
17. known significant diastolic dysfunction associated with clinical heart failure
boolean
C0520863 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Coronary Artery Disease | Heart valve disease
Item
18. known coronary disease or significant valvular heart disease
boolean
C1956346 (UMLS CUI [1])
C0018824 (UMLS CUI [2])
Congenital Heart Defects | Single Ventricle | Transposition | Eisenmenger Complex
Item
19. known congenital heart defects such as single ventricle, transposition, eisenmenger
boolean
C0018798 (UMLS CUI [1])
C3274516 (UMLS CUI [2])
C0040759 (UMLS CUI [3])
C0013743 (UMLS CUI [4])
Hypertrophic Cardiomyopathy | Left Ventricular Hypertrophy | Interventricular septum thickness increased | Posterior wall thickness increased
Item
20. known hypertrophic cardiomyopathy or left ventricular hypertrophy (interventricular septum thickness (ivs) or posterior wall thickness (pwd) >1.2 cm)
boolean
C0007194 (UMLS CUI [1])
C0149721 (UMLS CUI [2])
C3553443 (UMLS CUI [3])
C3553444 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs
Item
21. participation in any clinical drug trial within 4 weeks prior to screening of this study and/or who is scheduled to receive another investigational medicinal product (imp) during the course of this study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
22. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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